CN114072189A

CN114072189A - System for delivering inhalation therapy

Info

Publication number: CN114072189A
Application number: CN202080048527.5A
Authority: CN
Inventors: 尤瓦尔·阿夫尼
Original assignee: RESPINOVA Ltd
Current assignee: RESPINOVA Ltd
Priority date: 2019-05-08
Filing date: 2020-05-07
Publication date: 2022-02-18
Also published as: US20220211960A1; WO2020225817A1; EP3965859A1; JP2022532131A; EP3965859A4

Abstract

The inhaler includes: (a) a first channel having a first open end and a second open end; (b) a pressure source configured to generate a flow of gas; the pressure source is connected to the first open end of the first channel; (c) a rotary shutter configured to block and release the airflow; (d) a mouth in fluid communication with the second open end of the first channel; the inhaler further comprises a second channel having a first open end and a second open end; the first open end of the second passage is in fluid communication with the mouth; said second open end of said second channel being in communication with ambient air; the first and second channels are arranged such that the rotary shutter blocks and releases the first and second channels in an alternating manner.

Description

System for delivering inhalation therapy

Technical Field

The present invention relates to a medical device for the prevention and treatment of respiratory diseases and, more particularly, to an inhaler provided with inlet and outlet channels that are blockable and releasable in an alternating manner.

Background

WO2015186124 discloses a pulsatile therapy inhaler that produces pneumatic pulses for the treatment of respiratory disorders. The inhaler described above comprises: (a) a linear channel having an elongated shaft; the linear channel is configured to direct fluid flow in a laminar manner; (b) a patient interface fluidly connectable to an airway of a patient, the patient interface having an aperture fluidly connectable to a passageway; and (c) a shutter (shutter) disposed between the passage and the bore, the shutter configured to regulate fluid pressure within the fluid flow; the shutter comprises a disc having at least one cut-out and rotating about an axis parallel to the passage axis. The cutout has its four corner perimeters with two sides and two circumferential arcs configured relative to the axis of rotation. The side portions are circumferentially antisymmetrical with respect to the bore.

Pulsed inhalers known in the art have an air channel that supplies a flow of air into the airway of a patient. During the inhalation phase, air supplied by the inhaler flows into the airway of the patient. During the expiration phase, a portion of the exhaled air is returned into the air supply channel. The described effect is known as dead-space effect (dead-space effect). Therefore, there has long been a need to provide an inhaler which minimizes the above-mentioned effects and which expels exhaled air in its entirety.

Disclosure of Invention

It is therefore an object of the present invention to disclose an inhaler, comprising: (a) a first channel having a first open end and a second open end; (b) a pressure source configured for generating a flow of gas; the pressure source is connected to the first open end of the first channel; (c) a rotary shutter configured for blocking and releasing said airflow; (d) a mouth in fluid communication with the second open end of the first channel; the mouthpiece is configured to deliver a modulated flow of gas to an airway of a patient.

A core object of the present invention is to provide an inhaler comprising a second channel having a first open end and a second open end, the first open end of the second channel being in fluid communication with the mouthpiece. The second open end of the second channel is in communication with ambient air. The first and second channels are arranged such that the rotary shutter blocks and releases the first and second channels in an alternating manner.

It is another object of the present invention to disclose the first channel and the second channel adjacently arranged in a parallel manner.

It is another object of the invention to disclose the first channel arranged within the second channel.

It is another object of the present invention to disclose the first channel having a channel gate valve configured for controlling a flow rate within said first channel.

It is another object of the present invention to disclose the first passage having a branched inlet configured for connection to a humidifier unit.

It is another object of the present invention to disclose the nebulizer gate valve, selected from the group consisting of a mechanically actuated valve, an electrically actuated valve, a pneumatically actuated valve, a magnetically actuated valve, and any combination thereof.

It is another object of the present invention to disclose the nebulizer branch inlet, comprising a cylinder reciprocally displaceable within the nebulizer branch inlet between an open position for an inhalation phase and a closed position for an exhalation phase. In the open position, the nebulizer is fluidly connected with the mouth; the closed position blocks fluid communication between the atomizer and the mouth.

It is another object of the invention to disclose the atomizer capable of being connected to a source of gas pressure.

It is another object of the invention to disclose a connection for connecting said gas pressure source to said nebulizer, the connection comprising a gas pressure source gate valve.

It is another object of the present invention to disclose the atomizer capable of being connected to an oxygen source.

It is another object of the present invention to disclose the inhaler, comprising a control unit configured for controlling an element selected from the group consisting of said shutter, said channel gate valve, said humidifier gate valve, a gas pressure source gate valve, and any combination thereof; the control unit is preprogrammed for implementing a predetermined treatment protocol.

It is another object of the present invention to disclose the inhaler, which comprises a pressure sensor providing feedback to said control unit during the implementation of said predetermined treatment protocol.

It is another object of the present invention to disclose the inhaler, comprising a control unit configured for controlling an element selected from the group consisting of said shutter, said channel gate valve, said humidifier gate valve, a gas pressure source gate valve, said gas flow heater, and any combination thereof; the control unit is preprogrammed for implementing a predetermined treatment protocol.

It is another object of the present invention to disclose an inhaler, comprising a sensor selected from the group consisting of: a pressure sensor located at the first open end of the first channel and configured to detect a gas pressure provided by the pressure source, a flow rate sensor located at the first open end of the first channel and configured to detect a gas flow rate provided by the pressure sensor, a presence sensor located at the humidifier branch inlet and configured to detect a presence of the humidifier, a humidity sensor located at the humidifier branch inlet and configured to detect a humidity of the gas provided by the humidifier, a gas pressure sensor configured to detect a gas pressure of ambient air, an oxygen sensor located at the oxygen source, a presence sensor located at the nebulizer branch inlet and configured to detect a presence of the nebulizer, a pressure sensor located at the mouth and configured to detect a gas pressure within the mouth, a pressure sensor located at the mouth and configured to detect a gas pressure within the mouth, a pressure sensor located at the first open end of the first channel and configured to detect a gas flow rate provided by the pressure sensor, a presence sensor located at the humidifier branch inlet and configured to detect a presence of the humidifier, A lung gas sensor configured to detect a gas component of exhaled gas, a humidity sensor located at the mouth and configured to detect gas humidity within the mouth, a temperature sensor located at the mouth and configured to detect a temperature within the mouth, an acoustic sensor located at the mouth and configured to detect breath sounds within the airway of the patient, an acoustic sensor located at the body of the patient and configured to detect breath sounds within the airway of the patient, and any combination thereof.

It is another object of the present invention to disclose a method for preventing and treating respiratory diseases; the method comprises the following steps: (a) providing an inhaler further comprising (i) a first channel having a first open end and a second open end; (ii) a pressure source configured to generate a flow of gas; the pressure source is connected to the first open end of the first channel; (iii) a rotary shutter configured to block and release the airflow; (iv) a mouth in fluid communication with the second open end of the first channel; the mouthpiece is configured to deliver a modulated flow of gas to an airway of a patient; (v) the inhaler includes a second channel having a first open end and a second open end; the first open end of the second passage is in fluid communication with the mouth; said second open end of said second channel being in communication with ambient air; the first and second channels are arranged such that the rotary shutter blocks and releases the first and second channels in an alternating manner; (b) providing a pneumatic pulse to the mouth by blocking and releasing the air flow within the first channel; (c) the mouth is vented to ambient air. Steps b and c are performed in an alternating manner.

It is another object of the present invention to disclose the step of providing pneumatic pulses, including controlling a flow rate in said first channel by a channel gate valve configured.

It is another object of the present invention to disclose the step of providing pneumatic pulses, comprising humidifying said gas flow in said first passage by a humidifier connected to a branched inlet.

It is another object of the present invention to disclose the step of humidifying the gas flow, including controlling a flow rate between the humidifier unit and the first passage by a humidifier gate valve.

It is another object of the present invention to disclose the sub-step of humidifying the gas flow, comprising controlling a flow rate between the humidifier unit and the first channel by a humidifier gate valve.

It is a further object of the present invention to disclose the step of providing pneumatic pulses, comprising the sub-step of nebulizing the drug into said second channel.

Another object of the invention is to disclose the sub-step of nebulizing the drug, comprising positioning a reciprocally displaceable cylinder inside the nebulizer branch inlet in an open position of an inhalation phase and in a closed position of an exhalation phase, such that the nebulizer is fluidly connected with the mouth in the open position and blocks fluid communication between the nebulizer and the mouth in the closed position.

It is another object of the present invention to disclose the method comprising the steps of controlling a component selected from a group consisting of said electric motor, said tunnel gate valve, said humidifier gate valve, and any combination thereof; the control unit is preprogrammed for implementing a predetermined treatment protocol.

It is another object of the present invention to disclose the inhaler, comprising a step of controlling said element feedback selected from the group consisting of said electric motor, said channel gate valve, said humidifier gate valve and any combination thereof, including obtaining feedback from a pressure sensor.

Drawings

In order to understand the invention and to see how it may be carried out in practice, various embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

figure 1 is a schematic view of an inhaler provided with inlet and outlet channels that are blockable and releasable in an alternating manner;

FIG. 2 is a schematic view of an inhaler with a nebulizer;

figures 3a to 3d illustrate the operation of the gate valve;

FIG. 4 is a schematic diagram of a sensor arrangement in an inhaler;

FIG. 5 is a schematic view of an internal heater within an air channel;

figures 6a to 6c are schematic views of the arrangement of the conduits in the mouth of the inhaler; and

fig. 7a to 7d are schematic views of an alternative embodiment of a nebulizer gate valve in closed and open positions.

Detailed Description

The following description is provided to enable any person skilled in the art to make and use the invention and sets forth the best modes contemplated by the inventors of carrying out their invention. Various modifications, however, will remain readily apparent to those skilled in the art, since the general principles of the present invention have been defined specifically to provide inhalers for the prevention and treatment of respiratory diseases and methods of practicing the same.

Referring now to fig. 1, fig. 1 shows a schematic view of an inhaler 100, the inhaler 100 having a housing 150 that houses all of its components. Specifically, the air flow from the blower 20 is directed by the passage 10 in fluid communication with the mouth 50. The flow rate of the gas flow is controlled by a powered gate valve 120 driven by an actuator 110. The channel 10 is provided with a humidifier branch inlet 80 allowing fluid communication between a humidifier (not shown) connectable to the humidifier branch inlet 80. The second channel 40 is provided with a nozzle 30. Further, the second channel 40 is in fluid communication with a nebulizer branch inlet 90, the nebulizer branch inlet 90 being configured for connecting a humidifier thereto. The electric motor 70 drives the rotating disc 60 with cutouts (not shown) such that the first and

second channels

10 and 40 are respectively arranged such that the rotating disc 60 blocks and releases the first and

second channels

10 and 40 in an alternating manner. It should be noted that the excess pressure generated by the blower 20 when the cutouts (not shown) on the rotating disk 60 coincide with the first passages 10 is vented to the surrounding atmosphere when the cutouts coincide with the second passages 40. Only exhaled gas contained in the mouth 50 may be forced back into the patient's airway. In other words, the dead space effect is minimized.

Control unit 160 is configured to control electric motor 60, tunnel gate valve 120, humidifier gate valve 140, and gas pressure source gate valve 270. The control unit 160 is preprogrammed for implementing a predetermined treatment protocol. The pressure sensor 65 provides feedback to the control unit 160 during the delivery of a predetermined treatment regimen.

Referring now to fig. 2, an arrangement 200 for connecting a nebulizer 220 to an inhaler 100 (not shown) is presented. The nebulizer is connected to a nebulizer branch inlet 40, the nebulizer branch inlet 40 having a cylinder reciprocally displaceable within the nebulizer branch inlet 40 between a closed position 210 in an exhalation phase and an open position 210a in an inhalation phase. In the open position 210a, the nebulizer 220 is fluidly connected with the mouth 50.

Conduits

240 and 250 may be connected to an oxygen source and pressurized air, respectively. The oxygen flow rate is controlled by the cock 230. A gate valve 270 driven by the actuator 260 can be closed during the inspiration phase and can be opened during the expiration phase. Numeral 245 denotes an oxygen sensor that detects the flow of oxygen through the conduit 240.

Reference is now made to fig. 3a to 3d, which illustrate the operation of the gate valve. As shown in fig. 3a, the gate valves described above are shown as

shutters

120, 140 and 270. The shutter 120/140/270 is configured to open and block the channel 10/80/280. The shutter 120/140/270 is driven by an actuator 110/130/260. Fig. 3b to 3d show successive positions of the shutter 120/140/270, which progressively block the passage 10/80/280.

Referring now to fig. 4, a schematic diagram of a sensor arrangement in an inhaler is presented. The inhaler may comprise at least one of the sensors provided below.

The airflow from blower 20 within passageway 10 is characterized by an air pressure detected by pressure sensor 210 and a flow rate detected by flow rate sensor 211. Reference numeral 209 denotes an air pressure sensor configured to measure the pressure of ambient air. The obtained air pressure value is used by the control unit to calculate the air pressure provided into the mouth 50.

The mouth 50 may be provided with an air pressure sensor 203 and a flow rate sensor 202 that detect local air pressure and flow rate, respectively. The local relative humidity within the mouth 50 may be obtained by means of a humidity sensor 205 and a temperature sensor 206, respectively.

The acoustic sensor 201 located within the mouth 50 is designed to obtain an acoustic pattern of inhalation/exhalation phases via the airflow. In contrast, the acoustic sensor 190 may be placed on the chest of the patient. The acoustic patterns obtained by the sensors 201 and/or 190 may be used to adapt the treatment regime to the condition of a particular patient. Reference numeral 204 designates a sensor which detects the gas composition of the air exhaled by the patient.

The presence of the nebulizer 220 is reported by the nebulizer presence sensor 207. The presence of the humidifier is reported by a humidifier presence sensor 212. The humidity of the airflow at the inlet of the humidifier branch is detected by humidity sensor 208.

Referring now to fig. 5, a heater 220 mounted within the tunnel 10 is presented. The air flow directed by the channel 10 from the blower 20 to the mouth (not shown) may be heated as desired.

Reference is now made to fig. 6 a-6 d, which illustrate an alternative embodiment of the present invention in accordance with the concept of minimal dead space. It should be noted that in the passage 10, air pressure is directed to the mouth 50, while the passage 40(40a) provides fluid communication with the ambient atmosphere.

In particular, fig. 6a shows an inhalation channel 10 and an exhalation channel 40 a. There is no distance between the terminal ends of the

channels

10 and 40a and the mouth 50. Exhaled air is exhausted to the ambient atmosphere. In other words, there are no dead spaces in this embodiment. Similar to fig. 6a, in fig. 6b, the channel-defining housing 40 serves as an exhalation channel.

In fig. 6c, the suction channel 10 is displaced into the channel (housing) 40. After the expiration phase, the air in the space between the edge of the inhalation channel 10 and the mouth 50 is inhaled again.

An additional technical feature that distinguishes the embodiment of fig. 6a from the other two embodiments is to arrange the two

channels

10 and 40a adjacently in a parallel manner within the mouth 50. In contrast, fig. 6b and 6c present an arrangement in which the inhalation channel 10 is provided in the exhalation channel 40.

Referring now to fig. 7 a-7 d, schematic views of an alternative embodiment of a nebulizer gate valve in closed and open positions are presented. In particular, fig. 7a and 7b show a valve that can be opened pneumatically.

Numerals

300a and 300b refer to a closed position and an open position, respectively. The mechanically actuated valve is shown in closed position 310a and open position 310b in fig. 7c and 7d, respectively.

According to the present invention, an inhaler is disclosed. The inhaler includes: (a) a first channel having a first open end and a second open end; (b) a pressure source configured for generating a flow of gas; the pressure source is connected to the first open end of the first channel; (c) a rotary shutter configured to block and release the airflow; (d) a mouth in fluid communication with the second open end of the first channel; the mouthpiece is configured to deliver a modulated flow of gas to an airway of a patient.

A core feature of the present invention is to provide an inhaler comprising a second channel having a first open end and a second open end. The first open end of the second passage is in fluid communication with the mouth. The second open end of the second channel is vented to ambient air. The first and second channels are arranged such that the rotary shutter blocks and releases the first and second channels in an alternating manner.

According to one embodiment of the invention, the first channel and the second channel are arranged adjacently in a parallel manner.

According to one embodiment of the invention, the first channel is arranged within the second channel.

According to one embodiment of the invention, the first channel has a channel gate valve configured for controlling a flow rate within said first channel.

According to another embodiment of the invention, the first channel has a branched inlet configured for connection to a humidifier unit.

According to another embodiment of the invention, the nebulizer gate valve is selected from the group consisting of a mechanically actuated valve, an electrically actuated valve, a pneumatically actuated valve, a magnetically actuated valve, and any combination thereof.

According to another embodiment of the invention, the nebulizer branch inlet comprises a cylinder reciprocally displaceable within the nebulizer branch inlet between an open position for an inhalation phase and a closed position for an exhalation phase. In the open position, the nebulizer is in fluid connection with the mouth; the closed position blocks fluid communication between the atomizer and the mouth.

According to another embodiment of the invention, the nebulizer can be connected to a source of gas pressure.

According to another embodiment of the invention, the connection of the gas pressure source to the nebulizer comprises a gas pressure source gate valve.

According to another embodiment of the invention, the atomizer can be connected to a source of oxygen.

According to another embodiment of the invention, the inhaler comprises a control unit configured for controlling an element selected from the group consisting of the shutter, the channel gate valve, the humidifier gate valve, a gas pressure source gate valve, the gas flow heater and any combination thereof; the control unit is preprogrammed for implementing a predetermined treatment protocol.

According to another embodiment of the invention, the inhaler comprises a sensor selected from the group consisting of: a pressure sensor located at the first open end of the first channel and configured to detect a gas pressure provided by the pressure source, a flow rate sensor located at the first open end of the first channel and configured to detect a gas flow rate provided by the pressure sensor, a presence sensor located at the humidifier branch inlet and configured to detect a presence of the humidifier, a humidity sensor located at the humidifier branch inlet and configured to detect a humidity of the gas provided by the humidifier, a gas pressure sensor configured to detect a gas pressure of ambient air, an oxygen sensor located at the oxygen source, a presence sensor located at the nebulizer branch inlet and configured to detect a presence of the nebulizer, a pressure sensor located at the mouth and configured to detect a gas pressure within the mouth, a pressure sensor located at the first open end of the first channel and configured to detect a gas flow rate provided by the pressure sensor, a presence sensor located at the humidifier branch inlet and configured to detect a presence of the humidifier at the humidifier, A lung gas sensor configured for detecting a gas composition of exhaled gas, a humidity sensor located at the mouth and configured for detecting a gas humidity within the mouth, a temperature sensor located at the mouth and configured for detecting a temperature within the mouth, an acoustic sensor located at the mouth and configured for detecting breath sounds within the airway of the patient, an acoustic sensor located at the body of the patient and configured for detecting breath sounds within the airway of the patient, and any combination thereof.

According to another embodiment of the present invention, a method for preventing and treating respiratory diseases is disclosed, the method comprising the steps of: (a) providing an inhaler further comprising (i) a first channel having a first open end and a second open end; (ii) a pressure source configured to generate a flow of gas; the pressure source is connected to the first open end of the first channel; (iii) a rotary shutter configured to block and release the airflow; (iv) a mouth in fluid communication with the second open end of the first channel; the mouthpiece is configured to deliver a modulated flow of gas to an airway of a patient; (v) the inhaler includes a second channel having a first open end and a second open end; the first open end of the second passage is in fluid communication with the mouth; said second open end of said second channel being in communication with ambient air; the first and second channels are arranged such that the rotary shutter blocks and releases the first and second channels in an alternating manner; (b) providing a pneumatic pulse to the mouth by blocking and releasing the air flow within the first channel; (c) ventilating the mouth with ambient air. Steps b and c are performed in an alternating manner.

According to another embodiment of the invention, the step of providing pneumatic pulses comprises controlling the flow rate within the first channel by a configured channel gate valve.

According to another embodiment of the invention, the step of providing pneumatic pulses comprises humidifying said gas flow in said first passage by a humidifier connected to a branch inlet.

According to another embodiment of the invention, the step of humidifying the gas flow comprises controlling the flow rate between the humidifier unit and the first channel by a humidifier gate valve.

According to another embodiment of the invention, the sub-step of humidifying the gas flow comprises controlling a flow rate between the humidifier unit and the first channel by a humidifier gate valve.

According to another embodiment of the invention, the step of providing pneumatic pulses comprises the sub-step of nebulizing the drug into said second channel.

According to another embodiment of the invention, the sub-step of nebulizing the drug comprises positioning a reciprocally displaceable cylinder within the inlet of the nebulizer branch in an open position of an inhalation phase and in a closed position of an exhalation phase, such that the nebulizer is fluidly connected with the mouth in the open position and blocks fluid communication between the nebulizer and the mouth in the closed position.

According to another embodiment of the invention, the method comprises the step of a control unit configured to control an element selected from the group consisting of the electric motor, the tunnel gate valve, the humidifier gate valve, and any combination thereof; the control unit is preprogrammed for implementing a predetermined treatment protocol.

According to another embodiment of the invention, the inhaler comprises a step of controlling said element feedback selected from the group consisting of said electric motor, said channel gate valve, said humidifier gate valve and any combination thereof, including obtaining feedback from a pressure sensor.

Claims

1. An inhaler comprising:

a. a first channel having a first open end and a second open end;

b. a pressure source configured to generate a gas flow; the pressure source connected to the first open end of the first channel;

c. a rotary shutter configured to block and release the airflow;

d. a mouth in fluid communication with the second open end of the first passage; the mouth configured for delivering the modulated airflow to the patient's airway;

wherein the inhaler includes a second channel having a first open end and a second open end; the first open end of the second channel is in fluid communication with the mouth; the second open end of the second channel is in communication with the environment Air is in communication; the first passage and the second passage are arranged such that the rotary shutter blocks and releases the first passage and the second passage.

2. The inhaler of claim 1, wherein the first channel and the second channel are disposed adjacent in a parallel manner.

3. The inhaler of claim 1, wherein the first channel is disposed within the second channel.

4. The inhaler of claim 1, wherein the pressure source is selected from the group consisting of a blower, a compressed air bottle, a compressed air line, and any combination thereof.

5. The inhaler of claim 1, wherein the first passageway has a passageway gate valve configured to control flow rate within the first passageway.

6. The inhaler of claim 1, wherein the first channel has a humidifier branch inlet configured for connection to a humidifier unit.

7. The inhaler of claim 6, wherein the humidifier branch pipe has a humidifier gate valve configured to control the distance between the humidifier unit and the first passageway flow rate.

8. The inhaler of claim 1, wherein the rotary shutter is a rotary disc having cutouts and blocking and releasing the first and second passages in an alternating manner.

9. The inhaler of claim 1, wherein the rotary shutter is a rotary disk having a cutout and blocking and releasing the first channel and the second channel in a synchronized manner.

10. The inhaler according to claim 8 or 9, wherein the rotating disc is rotatably driven by an electric motor.

11. The inhaler of claim 1, wherein the second channel has a nebulizer branch inlet configured for connection to a nebulizer.

12. The inhaler of claim 1, wherein the nebulizer branch inlet comprises a nebulizer gate valve configured to control flow through the nebulizer branch inlet Rate.

13. The inhaler of claim 1, wherein the nebulizer gate valve is selected from the group consisting of mechanically actuated valves, electrically actuated valves, pneumatically actuated valves, magnetically actuated valves, and any combination thereof.

14. The inhaler of claim 12, wherein the nebulizer gate valve comprises a cylinder capable of an open position for an inspiratory phase and an expiratory phase within the nebulizer branch inlet In the open position, the nebulizer is in fluid connection with the mouth; the closed position blocks fluid communication between the nebulizer and the mouth.

15. The inhaler of claim 1, wherein the nebulizer is connectable to a gas pressure source.

16. The inhaler of claim 1, wherein the connection of the gas pressure source to the nebulizer comprises a gas pressure source gate valve, the gas pressure source gate valve can be closed during the inspiration phase and can be closed during the expiration phase. The gas phase can be opened.

17. The inhaler of claim 1, wherein the nebulizer is connectable to a source of oxygen.

18. The inhaler of claim 1, wherein the first channel includes an airflow heater configured to heat the airflow within the first channel.

19. The inhaler of claim 1, wherein the inhaler comprises a control unit configured to control an element selected from the group consisting of the shutter, the passage gate valve , the humidifier gate valve, the gas pressure source gate valve, the gas flow heater, and any combination thereof; the control unit is pre-programmed to implement a predetermined treatment regimen.

20. The inhaler of claim 18, comprising a sensor selected from the group consisting of: located at the first open end of the first passage and configured to detect a pressure sensor of air pressure provided by the pressure source, a flow rate sensor located at the first open end of the first channel and configured to detect the air flow rate provided by the pressure sensor, located at the humidification a presence sensor at the inlet of the humidifier branch and configured to detect the presence of the humidifier, a humidity sensor located at the inlet of the humidifier branch and configured to detect the humidity of the gas provided by the humidifier, configured to detect a barometric pressure sensor of ambient air pressure, an oxygen sensor located at the oxygen source, a presence sensor located at the nebulizer branch inlet and configured to detect the presence of the nebulizer, located at the mouth and a pressure sensor configured to detect air pressure within the mouth, a lung gas sensor configured to detect gas components of exhaled breath, located at the mouth and configured to detect gas humidity within the mouth a humidity sensor, a temperature sensor located at the mouth and configured to detect temperature within the mouth, an acoustic sensor located at the mouth and configured to detect breath sounds within the airway of the patient , an acoustic sensor located at a patient's body and configured to detect breath sounds within the patient's airway, and any combination thereof.

21. The inhaler of claim 18, wherein any sensor in the set provides feedback to the control unit during administration of the predetermined treatment regimen.

22. A method of preventing and treating respiratory diseases, the method comprising the steps of:

a. providing an inhaler, the inhaler further comprising:

i. a first channel having a first open end and a second open end;

ii. a pressure source configured to generate a gas flow; the pressure source connected to the first open end of the first channel;

iii. a rotary shutter configured to block and release the airflow;

iv. a mouth in fluid communication with the second open end of the first passage; the mouth configured for delivering the modulated airflow to the airway of a patient;

v. the inhaler includes a second channel having a first open end and a second open end; the first open end of the second channel is in fluid communication with the mouth; the second open end of the second channel is in fluid communication with the mouth ambient air communication; the first passage and the second passage are arranged such that the rotary shutter blocks and releases the first passage and the second passage;

b. providing a pneumatic pulse to the mouth by blocking and releasing the airflow within the first channel;

c. communicating the mouth with ambient air;

Said steps b and c are performed in an alternating manner.

23. The method of claim 21, wherein the step of providing a pneumatic pulse comprises controlling the flow rate within the first channel through a configured channel gate valve.

24. The method of claim 21, wherein the step of providing a pneumatic pulse includes the sub-step of humidifying the air flow within the first channel by a humidifier connected to a branch inlet.

25. The method of claim 23, wherein the sub-step of humidifying the airflow includes controlling the flow rate between the humidifier unit and the first passage through a humidifier gate valve.

26. The method of claim 21, wherein the step of providing a pneumatic pulse includes the sub-step of aerosolizing a drug into the second channel.

27. The inhaler of claim 25, wherein the sub-step of nebulizing the medicament comprises positioning a reciprocally movable cylinder within the branch inlet of the nebulizer at the opening of the inhalation phase position and a closed position for the exhalation phase such that the nebulizer is in fluid communication with the mouth in the open position and blocks fluid communication between the nebulizer and the mouth in the closed position .

28. The method of claim 21 including the step of a control unit configured to control an element selected from the group consisting of the electric motor, the channel gate valve, the humidifier gate valve, and the like Any combination; the control unit is pre-programmed to implement a predetermined treatment regimen.

29. The inhaler of claim 27, including the step of controlling the element feedback selected from the group consisting of the electric motor, the channel gate valve, the humidifier gate valve, the airflow heater, and the like Any combination, including feedback from pressure sensors.

30. The method of claim 21 including the step of providing feedback to the control unit via a sensor selected from the group consisting of being located at the first open end of the first channel a pressure sensor located at the first open end of the first passage and configured to detect the air pressure provided by the pressure source and configured to detect the airflow rate provided by the pressure sensor a rate sensor, a presence sensor located at the humidifier branch inlet and configured to detect the presence of the humidifier, a humidity sensor located at the humidifier branch inlet and configured to detect the humidity of the gas humidity provided by the humidifier a sensor, a barometric pressure sensor configured to detect the air pressure of ambient air, an oxygen sensor located at the oxygen source, a presence sensor located at the nebulizer branch inlet and configured to detect the presence of the nebulizer , a pressure sensor located at the mouth and configured to detect air pressure within the mouth, a lung gas sensor configured to detect gas components of exhaled air, located at the mouth and configured to detect A humidity sensor for gas humidity within the mouth, a temperature sensor at the mouth and configured to detect temperature within the mouth, at the mouth and configured to detect the patient's gas An acoustic sensor of breath sounds within the airway, an acoustic sensor located at a patient's body and configured to detect breath sounds within the patient's airway, and any combination thereof.

31. The method of claim 29, including the step of providing feedback to the control unit from any sensor of the group during administration of the predetermined treatment regimen.